BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 24697508 · Received March 26, 2026

    Report

    Report Number
    2245578-2026-00069
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CEM
    UDI-DI
    10054749005519
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # 1000273. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON 10-MAR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE K SAMPLE I-STAT (B)(6) 2026 >9.0 A LAB (B)(6) 2026 5.3 NI. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402489 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE CEM ABBOTT POINT OF CARE NA H25354 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1